From Laboratory to Patient: The Evolving Path to Become a Medicine
Gene editing and other laboratory developments promise to revolutionize treatment of many diseases that currently have no cure. The process to become a medicine is long and complex and requires many years. Regulation of medicines (permission to market a product and monitoring of its performance) is...
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| Format: | Article |
| Language: | English |
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World Scientific Publishing
2019-12-01
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| Series: | Molecular Frontiers Journal |
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| Online Access: | http://www.worldscientific.com/doi/pdf/10.1142/S2529732519400121 |
| _version_ | 1811266967593549824 |
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| author | Ana Hidalgo-Simon |
| author_facet | Ana Hidalgo-Simon |
| author_sort | Ana Hidalgo-Simon |
| collection | DOAJ |
| description | Gene editing and other laboratory developments promise to revolutionize treatment of many diseases that currently have no cure. The process to become a medicine is long and complex and requires many years. Regulation of medicines (permission to market a product and monitoring of its performance) is evolving to adapt to emerging new approaches in development. Current issues and new ideas needed to navigate the difficult waters from laboratory to patient are discussed here: novel approaches for narrow evidence base, earlier discussions of evidence with regulators, earlier planning for post-authorization requirements and better patient access. |
| first_indexed | 2024-04-12T20:53:52Z |
| format | Article |
| id | doaj.art-c4cb467c1fa74f6aa94f2bf1007ad674 |
| institution | Directory Open Access Journal |
| issn | 2529-7325 2529-7333 |
| language | English |
| last_indexed | 2024-04-12T20:53:52Z |
| publishDate | 2019-12-01 |
| publisher | World Scientific Publishing |
| record_format | Article |
| series | Molecular Frontiers Journal |
| spelling | doaj.art-c4cb467c1fa74f6aa94f2bf1007ad6742022-12-22T03:17:03ZengWorld Scientific PublishingMolecular Frontiers Journal2529-73252529-73332019-12-013213814610.1142/S252973251940012110.1142/S2529732519400121From Laboratory to Patient: The Evolving Path to Become a MedicineAna Hidalgo-SimonGene editing and other laboratory developments promise to revolutionize treatment of many diseases that currently have no cure. The process to become a medicine is long and complex and requires many years. Regulation of medicines (permission to market a product and monitoring of its performance) is evolving to adapt to emerging new approaches in development. Current issues and new ideas needed to navigate the difficult waters from laboratory to patient are discussed here: novel approaches for narrow evidence base, earlier discussions of evidence with regulators, earlier planning for post-authorization requirements and better patient access.http://www.worldscientific.com/doi/pdf/10.1142/S2529732519400121advanced therapyregenerative medicinegene therapysomatic cell therapytissue engineeringmedicine regulationregulatory agencieseuropean medicines agency (ema) |
| spellingShingle | Ana Hidalgo-Simon From Laboratory to Patient: The Evolving Path to Become a Medicine Molecular Frontiers Journal advanced therapy regenerative medicine gene therapy somatic cell therapy tissue engineering medicine regulation regulatory agencies european medicines agency (ema) |
| title | From Laboratory to Patient: The Evolving Path to Become a Medicine |
| title_full | From Laboratory to Patient: The Evolving Path to Become a Medicine |
| title_fullStr | From Laboratory to Patient: The Evolving Path to Become a Medicine |
| title_full_unstemmed | From Laboratory to Patient: The Evolving Path to Become a Medicine |
| title_short | From Laboratory to Patient: The Evolving Path to Become a Medicine |
| title_sort | from laboratory to patient the evolving path to become a medicine |
| topic | advanced therapy regenerative medicine gene therapy somatic cell therapy tissue engineering medicine regulation regulatory agencies european medicines agency (ema) |
| url | http://www.worldscientific.com/doi/pdf/10.1142/S2529732519400121 |
| work_keys_str_mv | AT anahidalgosimon fromlaboratorytopatienttheevolvingpathtobecomeamedicine |